Senior Regulatory Affairs Leader - Global Submissions

Endologix; California (MO); In loco; USD 110.000 - 128.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) retirement plan

Discretionary bonus

Equity participation

Descrizione del lavoro

Endologix is seeking a Sr. Regulatory Affairs Specialist to drive regulatory submissions and product updates across US, EU, and Canada. You will partner with R&D, Quality, and Manufacturing to ensure compliant, timely approvals for Endologix products.

The role requires extensive knowledge of FDA and EU MDR regulations, with a track record in Class III submissions and strong cross-functional collaboration.

Competenze

• Minimum 5+ years of medical device experience with 1+ years in Regulatory Affairs.
• Experience leading Class III regulatory submissions.
• In-depth knowledge of FDA, EU MDR and global medical device regulations.

Mansioni

• Develop, implement, and maintain regulatory processes and SOPs across global regions.
• Lead regulatory submissions and interact with authorities to support approvals.
• Provide strategic regulatory input to development teams and cross-functional partners.

Conoscenze

Regulatory affairs

Formazione

Bachelor's degree in scientific discipline

Master's degree with 1+ years of related experience

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Descrizione del lavoro

Endologix is seeking a Sr. Regulatory Affairs Specialist to drive regulatory submissions and product updates across US, EU, and Canada. You will partner with R&D, Quality, and Manufacturing to ensure compliant, timely approvals for Endologix products.

The role requires extensive knowledge of FDA and EU MDR regulations, with a track record in Class III submissions and strong cross-functional collaboration.